Patient- and Physician-Based Osteoporosis Education

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00073190
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), Arthritis Foundation (Other)
30,000
1
33
909.5

Study Details

Study Description

Brief Summary

Osteoporosis is an important public health problem. Osteoporosis can cause serious health complications and death and leads to increased medical costs. The purpose of this study is to identify an effective method of educating patients and health care professionals about the diagnosis and treatment of osteoporosis.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Osteoporosis Education
Phase 1

Detailed Description

Osteoporosis affects a large and growing proportion of the population. Multiple drugs for the prevention and treatment of osteoporosis have been developed, tested, and proven effective in the last decade. However, these drugs may not always be adequately prescribed. Several effective nonpharmacological measures also exist for preventing fractures; strength and gait training, home safety modifications, and other lifestyle modifications have all been shown in carefully conducted trails to reduce the risk of falls that lead to osteoporotic fractures. Yet these interventions are under-utilized. Practical public health strategies are needed to bring these experimental findings to widespread use in typical populations of at-risk patients. This study will evaluate innovative fracture prevention interventions targeted to both patients and doctors. Specifically, the study will compare the effects of the patient and physician behavior change intervention alone and in combination on prescribing patterns for osteoporosis therapies and will examine the interventions' effects on fracture prevention behaviors other than medication use.

The patient intervention will consist of two mailings and will be targeted using clinical and demographic data from the State of Pennsylvania's Pharmaceutical Assistance Contract for the Elderly (PACE) and Medicare databases. The first mailing will introduce the topic of osteoporosis and explain why osteoporosis is an important topic for all those receiving the mailing. The second mailing, sent the following month, will reinforce the first mailing and contain patient-specific information based on demographic and clinical factors. This mailing will also focus on several proven prevention strategies, including strength and gait training, vision care, home safety improvements, calcium intake, and pharmaceutical enhancement of bone density.

The physician intervention will be multifaceted and will include a mailed practice audit and one-on-one education through academic detailing. The mail audit will contain information on the physician's PACE patients and an assessment of their osteoporosis risk based on clinical and drug data. Following the mailing, an academic detailer will meet with the physicians receiving the intervention.

Outcome measures will include questionnaires, medication use, Dual Energy X-ray Absorptiometry (DEXA) scans, and use of physical therapy.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single
Official Title:
Randomized Controlled Testing of Osteoporosis Education
Study Start Date :
Sep 1, 2003
Actual Primary Completion Date :
Jun 1, 2006
Actual Study Completion Date :
Jun 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria For Patients:
    • PACE beneficiaries who filled at least one prescription for a drug of any type in the year prior to the study

    • At high risk for osteoporosis: women and men 75 years or older, patients taking glucocorticoids or psychoactive medications, patients diagnosed with rheumatoid arthritis, and patients with a past fracture

    • Have had an outpatient visit with a participating doctor based on Medicare outpatient claims

    Inclusion Criteria For Physicians:
    • Primary prescribing physicians for PACE beneficiaries

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Daniel H. Solomon MD, MPH Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital
    • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    • Arthritis Foundation

    Investigators

    • Principal Investigator: Daniel H. Solomon, MD, MPH, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Daniel H. Solomon, M.D.,MPH, Professor of Medicine, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT00073190
    Other Study ID Numbers:
    • K23AR048616
    • K23AR048616
    • NIAMS-074
    First Posted:
    Nov 18, 2003
    Last Update Posted:
    Dec 16, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Daniel H. Solomon, M.D.,MPH, Professor of Medicine, Brigham and Women's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 16, 2013